Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, December 16, 2013

In marketing we trust

When is science not science? When you read about it in e-mail or see it on TV.  Hyperbole in advertising is universal and the more ludicrous the claim, the less it seems to violate FTC truth in advertising laws at least in terms of enforcement. I'm not talking about the ability of advertisers to distract from facts, like running a Toyota Camry through some kind of  roller coaster contraption to 'prove' that's it's not a boring, soulless transportation appliance for dull people, or inventing "the star safety system" to distract from stories about how people are dying because of it's defects. I'm not even talking about TV ads claiming that after driving a Nissan, the speed of light doesn't seem so fast or showing SUVs beating sports cars on a track.  I'm talking about the level of deceit in the marketing of health and science products and advice -- the kind of pervasive disinformation that makes people believe they can eat double bacon cheeseburgers with impunity as long as they don't eat the bun -- eat chili cheese fries  and lose weight by buying Dr. Oz's magic beans and miracle berries, or put their faith in "the proven science of the glycemic index" as though an index could be science. -- as though that handsome guy in the lab coat were a real scientist and his doctorate not in marketing.

It's about the kind of massive promotion of ideas about gluten and fructose that have no scientific support, about making your brain work better by doing 'exercises' that really doesn't have support from neuroscience as claimed, about getting "grain brain" or removing those mysterious "toxins" from your blood or colon. Never mind none of these "studies" ever appear in professional, peer reviewed journals, but only in advertising. Never mind that what they call "studies" never are more than anecdotes, inventions, gross distortions and deliberate misrepresentations.  You just can't get to the science through the smokescreen of marketing -- and in marketing we trust.

We live in an age of snake oil where all it takes is some actor in a white coat, some diet book salesman posing as a scientist to convince our gullible nation that unhealthy things will make them well, that lethal germs and 'toxins' are lurking under the bed, that green tea or green coffee beans or Doctor Bonkers' Egyptian Oil will let them eat 10,000 calories a day while they stay thin and live forever. The sun will kill you quick, we just know it and even on cloudy days and even wrapping yourself like a Bedouin in wool won't help unless the clothing has extra sun protection chemicals in it. Your kitchen counter of course is a dangerous place that needs to be laved with "anti-bacterial" products lest your family die horribly and everything we touch has to be anti-bacterial. Does it surprise you that SPF 50 doesn't give you twice the protection of SPF 25 -- hell no and while the marketing guys smile we cover ourselves with lead foil and hide in the basement.

UV and Toxins and Germs, oh my! Unless you buy anti-bacterial products you'll be eaten alive by bacteria, no matter that there are more of them inside and all over you than there are people in the world and you wouldn't be healthy otherwise. Anti-bacterial soap, lotion, shampoo, body wash, eye drops, sprays, food, gels, creams, toothpastes -- there are kitchen utensils, toys, bedding, socks, and trash bags -- we're told to be afraid of such things on the food we eat, but we're soaking in it. is it even practical, necessary, healthy or smart to attempt living in a bacteria free bubble? Is that attempt involved with all the allergies everyone seems to have these days?


We never ask what anti-bacterial means, do we?  If cleaning our hands with soap and water removes adequate amounts of bacteria according to real double blind scientific studies, we still want to be righteous and hip and enlightened and we don't bother to ask why some chemical that prevents bacteria from reproducing is needed after the bacteria already has been removed by plain water.  We all feel much better eating "organic" food in the faith based belief that chemicals used by those farmers are safer than the chemicals used by regular farmers and the food is healthier and more nutritious. We obsess about unnamed "toxins" and chemicals and preservatives but we don't ask if long term exposure to the serious toxins in anti-bacterial products might have side effects. But hey, better safe than sorry, right? and if it's on TV it must be true!

There are at least 2000 anti-bacterial products on the market says the FDA.  They're finally going to begin to ask for evidence that they are safe. It's about time. In fact scientists have been pressing for the FDA to remove one chemical, triclosan, that interferes with the thyroid gland in rats, since 1978 even though there is no evidence that soaps containing it are any more effective at preventing disease in your home than washing with plain soap and water. The Government is  finally going to demand evidence of safety and effectiveness and it's about time!

  

Monday, November 23, 2009

NEW MAMMOGRAM GUIDELINES: MORE NOISE THAN SCIENCE

Last week, the U.S. Preventive Services Task Force issued new mammogram screening guidelines that have stirred considerable controversy in political and scientific circles. If the taskforce report were credible and convincing, there would be no need to suspect a hidden motive. However, these findings are deeply flawed and highly suspect. Here is a synopsis of findings released by the taskforce:

Credit: (O)CT(O)PUS


According to the taskforce: If you screen 1,904 women in the 40 to 49 year-old age group, there is a high probability of preventing one cancer death. Similarly, to prevent one cancer death in the 50s age group, you would have to screen 1,339 women. It goes without saying that cancer risks increase with age, meaning that women in older age groups are more likely to test positive for cancer than women in younger age groups.

With simple arithmetic, you can estimate how many lives per million can be saved. For women in the 40s age group: If you screen 1,904 women to save one life, it is reasonable to assume that you can save 525 lives if a million women were screened. What does this mean when applied to the U.S. population? According to the U.S. Census Bureau (Table 1), there are 22,346,000 women in the 40s age group (14.7%). When you divide this population by 1,904, the probabilistic number of lives that can be saved is 11,736.

If you accept this assumption, then you cannot accept these findings of the U.S. Preventive Services Task Force, which state (source):

The USPSTF recommends against routine screening mammography in women aged 40 to 49 years (...) This is a C recommendation.

The USPSTF recommends against teaching breast self-examination (BSE). This is a D recommendation.

In other words, the taskforce recommends no mammogram screenings for women in the 40s age group and no breast self-examinations for women of any age. Why? According to the study panel, the relative risks outweigh the benefits, i.e., risk factors such as false-positive test results, anxiety, and pain from increased biopsy rates resulting from over-diagnoses. Yet, there are contradictory statements within the taskforce report, such as:

Breast cancer mortality has been decreasing since 1990 by 2.3% per year overall and by 3.3% for women aged 40 to 50 years. This decrease is largely attributed to the combination of mammography screening with improved treatment.

On one hand, the study panel recommends a reduced screening regimen for women in the 40s age group yet attributes reductions in mortality to a “combination of mammography screening with improved treatment.” How contradictory!

If you think these conclusions are strange, the measurements of relative risks are even more contradictory. According to the taskforce report, the relative risks are virtually identical for both groups: 15% for the 40s age group, and 14% for the 50s group. In other words, the tradeoff is more peace of mind within the context of “ignorance is bliss.” Either the data are internally inconsistent, or the conclusions contradict the data, or Aesop wrote the final study report.

A few words about methods and statistics: It seems different branches of the federal government employ different research protocols. If this were the FDA, for instance, no report would pass muster if it did not include at least one domestic study covering these age distributions. The USPSTF report includes only one domestic study for the 40s age group, but none covering the 50s age group. Other meta-analyses are based on non-domestic data sets that are less representative of U.S. population demographics.

Furthermore, the USPSTF report applies less than rigorous statistical methods. For example, the study panel uses the term “credible interval” instead of the more conventional term “confidence interval” as a measure of statistical validity. By definition, the term “credible interval” is a subjective subset of the confidence interval … implying considerable wiggle room to employ a fudge factor when one wants to force data into a preconceived conclusion.

Why are substandard study methods and statistics being used to justify new mammogram screening guidelines? Consider this comment by one of our Swash Zone writers under my last post on this subject (link):

maleeper (@11:02 AM, November 20, 2009): “Thanks for raising the issue of the USPSTF ill-advised report on breast cancer. The study was commissioned during the Bush administration, which may be why no oncologists or radio-therapists served on the study panel.

According to the American College of Radiology, the USPSTF recommendations ignored direct scientific evidence from large clinical trials and "also ignored peer reviewed journal articles that critqued studies on which their recommendations rely."

One trial that was used for the study was translated from Russian to English so that it could be used in the study, while many reputable articles were ignored.

Such selectivity in sources cited leads me to believe that the taskforce may have decided the results it wanted ahead of time, since they clearly will save money for insurance companies for a few years. The USPSTF panel then found studies to back up their assumptions, regardless of the cost of human life.

What do you get when junk science conspires with junk journalism? You get editorials like this one from the New York Times:

There is nothing wrong with a healthy public debate about mammography within the medical community and among women who must decide when and how often to get screened. It should not be injected into the partisan debate over health care reform.

Unless, of course, the findings of the taskforce are specious and suspicious.

Thursday, November 19, 2009

NEW MAMMOGRAPHY GUIDELINES: FIRST IMPRESSIONS

About the new guidelines for breast cancer screening, the American Cancer Society, the American College of Radiology (ACR), and the American College of Obstetricians and Gynecologists (ACOG), among others, find the new recommendations “objectionable.”

Shawn Farley, the director of public affairs for ACR, says: :

"If the USTSF recommendations are adopted as policy — particularly if Medicare and private insurers try to use them as an excuse to cut cost — many women will die unnecessarily from breast cancer (...) The treatment costs associated with the disease may rise because cancers would be found at a more advanced stage. For those women diagnosed at a later stage, they may experience more invasive techniques to remove the cancers because the disease is more advanced."

And here is the most damnable part: Not one, I repeat, NOT ONE oncologist served on the panel that recommended those revisions. To quote the source: “Let us just hope that our mostly male legislators and insurance CEOs have women that they are very fond of, and will work to protect this group of mostly female victims.” Never count on the goodwill of sexist pigs ... especially insurance company pigs and their Congre$$ional lackeys.

This post is a work-in-progress. Please look for a more detailed analysis on Monday.

Wednesday, July 29, 2009

Regulation is bad for business

One of the favorite targets of libertarians and "smaller government" arguments is the FDA. The market should, could and would preserve us from tainted, unsafe and worthless products, just the way it didn't in the 19th century. Perhaps there's some truth to that, but the store window where the idea is sold doesn't contain a display of all the poisoned, sickened and fleeced consumers waiting to be redeemed or resurrected while the market forces grind on in the darkness of unregulated capitalism.

Of course the FDA, or what remains of it after years of Republican misrule can't do much better it seems and the free press that's supposed to be an agent of illumination in a libertarian utopia doesn't care to try. Witness today at CNN.com an article telling us that products widely being sold as steroid free, body-building aids do actually contain dangerous synthetic steroids and can, in several ways, kill you. Thanks CNN.

Of course prominently displayed on the home page is a photo of a grotesquely, steroidal male torso which links to an ad for the very things the FDA is telling people to avoid like the plague they apparently are. "Safe, natural, legal!" Never mind that little liver failure thing.

The solution is clear. We really need to get rid of the FDA and that damned government regulation - bad for business, don't you know.